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StrokeKOMPACTNCT04720820

Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea

A study testing Early Supported discharge with home based Rehabilitation and Conventional rehabilitation in people with Stroke, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aims to examine the effect of early supported discharge (ESD) service on the functional outcomes and quality of life of acute stroke patients with mild to moderate disability in Korea. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stroke
What is being tested?
Early Supported discharge with home based Rehabilitation and Conventional rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteSouth Korea
Study dates
1 Mar 2021to 29 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient who is over 20 years old
  • Patient who had acute stroke and admitted to hospital (excludes TIA)
  • Patient who will be discharged to home within 30 days after onset
  • Patient who has indwelling caregiver and is able to support in ESD program
  • Patient who's initial mRS is 1-3
  • Patient who's initial FAC is 3 or above
  • Patient who's initial K-NIHSS consciousness scores (1a,1b,1c) are all 0

Who cannot join

  • Patient who had Transient Ischemic Attack
  • Patient who is medically unstable requiring intense treatment
  • Patient who has indwelling urinary catheter
  • Patient who is unable to intake food by mouth
  • Patient who is initial MMSE is below 15
  • Patient who has uncontrolled pain
  • Patient who has psychobehavioral problems

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

    Seongnam-si, Korea, Gyeonggi-do, 463-707

Other trials in South Korea

About this study

Official title: A Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge: KOrean Model of Post-Acute Comprehensive rehabiliTation(KOMPACT)

The study aims to examine the effect of early supported discharge (ESD) service on the functional outcomes and quality of life of acute stroke patients with mild to moderate disability in Korea.

The study is a double-armed prospective multi-centered, assessor-blinded randomized controlled trial comparing the effect of ESD program with conventional rehabilitation program.

Read the detailed description

Early Supported Discharge (ESD) is a form of medical service applicable to acute stroke patients with mild to moderate disabilities. ESD service was developed to facilitate patient to their daily livings at home, reduce the length of stay in the hospital with possibly better or equivalent outcomes for patients and caregivers.

ESD service has been proven to be non-inferior in the functional and quality of life measures as well as cost-effective, compared to the conventional rehabilitation service in many countries, however the effectiveness of ESD service may differ among countries and medical, economical circumstances. This study aims to examine the effect of ESD service on the acute stroke patients with mild to moderate disabilities in Korea and demonstrate its feasibility as an alternative medical service option to those patients.

Conditions
Stroke
Being tested
Early Supported discharge with home based Rehabilitation, Conventional rehabilitation
Keywords
Early Supported Discharge, Acute stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Supported discharge with home based RehabilitationOther

    Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.

  • Conventional rehabilitationOther

    Treatment will be provided according to current hospital's stroke rehabilitation program.

Study groups in NCT04720820
Study groupRoleWhat they receive
Early Supported Discharge (ESD) GroupExperimentalPatients in the ESD group will be discharged to home as soon as the acute medical treatment is finished. The patients will follow a pre-planned ESD program which consists of home-based rehabilitation (at least 30 minutes of physical therapy and 30 minutes of occupational therapy per week) offered by therapists. The ESD team will also provide social/medical services as needed. The ESD program will be provided till 1 months after discharge point.
Receives: Other: Early Supported discharge with home based Rehabilitation
Conventional Rehabilitation (CR) GroupActive comparatorThe patients in CR group will be provided with inpatient rehabilitation after the acute medical treatment is finished. The length of inpatient rehabilitation may depend on the hospital's current program. Patients will be provided with outpatient based rehabilitation program if needed after discharge.
Receives: Other: Conventional rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in Korean modified Barthel Index (K-MBI)

    K-MBI is an ordinal scale used to measure performance in activities of daily living(ADL). score ranges from 0 to 100, higher score meaning better ADL function.

    Measured: Baseline, 1 month after discharge, 3 months after onset, changes from baseline

Secondary outcomes (13)

  1. modified Rankin Scale (mRS)

    mRS is a scale used for measuring the degree of disability or dependence in the daily activities of people with stroke. Scale ranges from 0-6, with 0 meaning no symptoms and 6 meaning dead.

    Measured: Baseline, 1 month after discharge, 3 months after onset

  2. Korean Instrumental Activities of Daily Living (K-IADL)

    K-IADL assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances. The scale ranges from 0 to 100, higher score meaning better IADL function.

    Measured: 1 month after discharge, 3 months after onset

  3. Korean Reintegration to Normal Life Index (K-RNLI)

    K-RNLI assesses the degree of individuals who have experienced stroke achieve reintegration into normal social activities. The scale ranges from 0-100 with higher score meaning better reintegration to normal life.

    Measured: 1 month after discharge, 3 months after onset

  4. Patient Health Questionnaire-9 (PHQ-9)

    PHQ-9 is a instrument for screening, diagnosing and measuring the severity of depression. The scale ranges from 0-27 with higher score indicating severer depression.

    Measured: Baseline, 1 month after discharge, 3 months after onset

  5. Korean Stroke Impact Scale ver 3.0 (K-SIS)

    K-SIS evaluates disability and health-related quality of life after stroke. It consists of 8 domains each score ranges from 0-100 with higher score meaning better quality of life.

    Measured: 1 month after discharge, 3 months after onset

  6. European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)

    EQ-5D-5L evaluates the quality of life. The scale ranges from -0.066 to 0.904, lower value means worse quality of life.

    Measured: Baseline, 1 month after discharge, 3 months after onset

  7. Fall Experience

    Number of patients who experience fall within the period.

    Measured: 1 month after discharge, 3 months after onset

  8. Mortality rate

    Number of patients who died within the period.

    Measured: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

  9. Readmission rate

    Number of patients who were readmitted to the hospital within the period.

    Measured: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

  10. Length of hospital stay

    Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.

    Measured: 3 months after onset

  11. Korean Zarit Burden Interview-22 (K-ZBI 22)

    K-ZBI 22 assesses caregiver perceptions of burden in health, personal, social or financial domains. The scale ranges from 0-88 with higher score indicating higher burden.

    Measured: 1 month after discharge, 3 months after onset

  12. Direct costs related to rehabilitation

    Direct costs includes expenses for medical and rehabilitation services. It consists for inpatient cost, outpatient cost, home based rehabilitation cost.

    Measured: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

  13. Indirect costs related to rehabilitation

    Indirect costs means expenses needed for treatment and rehabilitation of the patients other tahn medical and rehabilitation services. Indirect costs include transportation expense and caregiver expense and productivity loss

    Measured: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start1 Mar 2021
  3. Primary completion29 Nov 2023
  4. Study completion29 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The trial consists of two arms; An Early Supported Discharge group and Conventional Rehabilitation group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04720820
Sponsor's protocol ID
B-2012-654-308
Acronym
KOMPACT
Status last verified
Nov 2023
First submitted
20 Jan 2021
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chang WK, Jung YS, Choi JS, Kim WS, Sohn MK, Jee S, Shin YI, Ko SH, Ock M, Kim HJ, Paik NJ. Pragmatic multicenter randomized controlled study on early supported discharge after stroke in Korea: the KOMPACT study. Ann Phys Rehabil Med. 2025 Nov;68(8):102025. doi: 10.1016/j.rehab.2025.102025. Epub 2025 Sep 18.

    PubMed 40972310

  • Chang WK, Kim WS, Sohn MK, Jee S, Shin YI, Ko SH, Ock M, Kim HJ, Paik NJ. Korean Model for Post-acute Comprehensive rehabilitation (KOMPACT): The Study Protocol for a Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge. Front Neurol. 2021 Sep 8;12:710640. doi: 10.3389/fneur.2021.710640. eCollection 2021.

    PubMed 34566853

Questions about this trial

What is this clinical trial studying?

A study testing Early Supported discharge with home based Rehabilitation and Conventional rehabilitation in people with Stroke, run by Seoul National University Bundang Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in Korean modified Barthel Index (K-MBI) (time frame: Baseline, 1 month after discharge, 3 months after onset, changes from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04720820, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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